- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766583
A Phase IB Study Of The BTKi CC-292 Combined With Lenalidomide In Adults Patients With Relapsed/Refractory B-Cell Lymphoma (CLEAR)
A PHASE IB STUDY OF THE BTKi CC-292 COMBINED WITH LENALIDOMIDE IN ADULTS PATIENTS WITH RELAPSED/REFRACTORY B-CELL LYMPHOMA
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Créteil, France, 94010
- Hôpital Henri Mondor
-
Lille, France, 59037
- CHU de Lille
-
Marseille, France, 13273
- Institut Paoli Calmette
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Nantes, France, 44093
- CHU de Nantes
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Pierre Bénite, France, 69495
- CHU Lyon Sud
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Toulouse, France, 31059
- CHU de Toulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histology:
- Patients with any type of B-cell Lymphoma except CLL, SLL and Waldenström disease will be eligible during the dose escalation phase
- During the expansion phases, patients with DLBCL for cohort A, mantle cell lymphoma for cohort B and any other type of B-cell lymphoma except CLL, SLL and Waldenström disease for cohort C.
Other criteria:
- Signed inform consent
- Patients should be relapsed or refractory NHL after ≥1 prior Rituximab-containing regimen for which no other type of therapy is of higher priority
- Aged 18 years or more.
- ECOG performance status 0-2.
- Measurable disease defined by at least one single node or tumor lesion > 1.5 cm.
- Life expectancy of ≥ 90 days (3 months).
- Patients must be eligible and willing to undergo excisional biopsies of tumor sites with a lymph node of minimum 1 cm at baseline and after 21 days of treatment
- Females of childbearing potential (FCBP)† must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL before starting lenalidomide - the first test must be performed within 10-14 days before starting lenalidomide treatment and the second test must be performed within 24 hours before starting lenalidomide
- FCBP must either commit to continued abstinence from heterosexual intercourse or begin two methods of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
- Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
Exclusion Criteria:
Previous treatment with lenalidomide or a BTK inhibitor. Central nervous system or meningeal involvement. Contraindication to any drug contained in this regimen Concomitant use of medicines known to cause QT prolongation or torsades de pointes HIV disease, active hepatitis B or C. Any serious active disease or co-morbid medical condition (according to investigator's decision);
Any of the following laboratory abnormalities :
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 80,000/mm3 (80 x 109/L)
- Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN).
- Serum total bilirubin > 1.5 ULN except in case of hemolytic anemia and Gilbert's syndrome.
Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or Incidental histological finding of prostate cancer [TNM stage of T1a or T1b]) unless the subject has been free of the disease for ≥ 5 years Any serious medical condition, laboratory abnormality, or psychiatric illnessthat would prevent the subject from signing the informed consent form.
Pregnant or lactating females. Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide and/or pomalidomide.
Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide and/or pomalidomide.
Subjects with ≥ Grade 2 neuropathy. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
Chronic use of proton pump inhibitors, H2 antagonists or antacids or their use in the last 7 days prior to the first CC-292 dose. Patients with chronic gastroesophageal reflux disease, dyspepsia, and peptic ulcer disease, should be carefully evaluated for their suitability for this treatment prior to enrollment in this study. These medications should be avoided throughout the study.
Patients taking corticosteroids during the 4 weeks prior to inclusion, unless administered at a dose equivalent of ≤ 10 mg/day prednisone (over these 4 weeks).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CC-292 + lenalidomide
Combination of CC-292 + lenalidomide
|
CC-292 + lenalidomide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of the recommended dose of CC-292 and lenalidomide in patients with relapsed/refractory B-cell lymphoma
Time Frame: 28 days
|
The optimal CC-292 and lenalidomide combination will be determined based on the maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and/or the analysis of adverse events, serious adverse events and toxicities observed during the study
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
preliminary efficacy signals of the CC-292 + Lenalidomide combination
Time Frame: 6 months
|
Overall response rate and overall response rate, complete and partial response rates, progression free survival, response duration, time to next treatment and overall survival
|
6 months
|
Observed maximum plasma concentration
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
|
time to reach maximum observed plasma concentration (Tmax)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
|
Terminal phase rate constant (λz)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
|
plasma decay half-life (t1/2)
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
|
Area under the curve from time zero to the last quantifiable concentration [AUC(0-t)]
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
Area under the plasma concentration versus time curve from time zero (predose) to time of the last quantifiable concentration (0-t)
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
Area under the curve from time zero to extrapolated infinity [AUC(0-∞)]
Time Frame: 0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
Area under the plasma concentration versus time curve (AUC) from time zero (predose)to extrapolated infinity(0-∞)
|
0, 0.5, 1, 2, 4, 6, 8 hours post dose
|
BTk receptor occupancy
Time Frame: 0 (predose) and 21 days post dose
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BTK receptor occupancy will be determined in the peripheral blood cells and tumor tissue
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0 (predose) and 21 days post dose
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Gilles Salles, PhD, CHU Lyon - Sud - LYSA
- Study Chair: Loïc YSEBAERT, MD, CHU de Toulouse LYSA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- CLEAR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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